Bleed back control assembly and method

ABSTRACT

A bleed back control assembly and method for controlling blood loss during catheterization procedures includes a side arm body connected at the proximal end to a seal body. The side arm body comprises one or more branches, each having a lumen, and a finger rest on the exterior of at least one branch. The seal body comprises a cap assembly and a seal assembly. The seal assembly comprises a clamp seal and a bleed back seal, both made of elastomer and held by a seal holder. The cap assembly comprises a threaded cap and a funnel cap. The threaded cap is connected to the seal holder. Rotation of the threaded cap causes the clamp seal to open or close. The funnel cap comprises a dilator, and pressing the funnel cap causes the dilator to open an aperture in the bleed back control seal. A spring, wound around the dilator, returns the funnel cap to its original position, thus closing the bleed back seal. The bleed back seal self-sizes to devices introduced through its aperture. Dilating the bleed back control seal also allows purging of gases or fluids. The clamp seal can clamp a device introduced transluminally to maintain device position, and the clamp seal may also be closed to allow high pressure injections.

BACKGROUND

This invention relates generally to a bleed back control assembly forcontrolling blood loss during vascular diagnostic or interventionalprocedures, such as insertion and removal of catheters from a patient'sblood vessels.

Treatment of patients with diseases, such as coronary heart disease, cantypically involve use of catheters, balloon catheters, stents, and othervascular intervention devices which are introduced transluminally, i.e.to and through the interior of a patient's blood vessels. Typically,catheterization procedures include the use of a hemostatic valve toreduce blood loss.

It is known in the art to provide a large bore rotating hemostasis valve(RHV) which attaches to the end of a guiding catheter and acts as anopen/close valve. After a device is introduced into the lumen of an RHV,the RHV serves as a seal around the device to reduce blood loss. An RHVmust be opened to allow introduction of an interventional device intothe RHV's lumen, and must be closed to control blood loss while allowingdevice adjustment, such as moving it back and forth. A doctor mustadjust a screw cap of a conventional RHV in order to adjust the sealaround various devices introduced axially through the RHV's lumen.Conventional RHV's utilize a Touhy-Bourst seal design, which may beopened and closed by the user, but such a seal allows fluid to escapeuntil properly adjusted.

A significant amount of the patient's blood may be lost during theseadjustments of the RHV's screw cap which are required in order to move adevice, such as a catheter, in and out of the RHV. When the RHV is notadjusted to seal around the device introduced in the RHV's lumen, thereis no mechanism for inhibiting substantial bleed back or blood loss.

Accordingly, a conventional RHV allows excessive blood loss when the RHVis not adjusted or whenever the RHV is in the open position. Thisdrawback in an RHV allows for excessive and undesirable blood loss fromthe patient. The excessive blood loss also creates a more ensanguinedoperating environment for the user of the RHV, increasing risksassociated with unwanted exposure to blood (or other fluids) and makingmore difficult the manipulation or operation of devices.

For example, U.S. Pat. No. 5,269,764, issued to Vetter et al., disclosesa hemostatic gasket and valve assembly, including a terminal plug, whichcan be rotated and thus tightened to cause radial compression of thehemostatic gasket.

SUMMARY

An advantage of the present invention is to provide a bleed back controlassembly which permits diagnostic or interventional vascular procedures,such as insertion of devices like catheters, guide wires, or stentdelivery systems in a patient's blood vessels, while controlling andsignificantly reducing the amount of blood loss, even when the cathetermust be adjusted or moved.

Another advantage of the invention is to provide a bleed back controlassembly which permits diagnostic or interventional vascular procedures,while allowing a user to clamp an interventional device introduced intothe bleed back control assembly, to maintain device position whilecontrolling blood loss.

A bleed back control apparatus in accordance with one aspect of theinvention includes a side arm body having proximal and distal ends, anda seal body connected to the proximal end of the side arm body, wherethe seal mechanism includes a seal assembly and a cap assembly. The sealassembly comprises a bleed back control seal held within an interiorchamber of a seal holder.

In another aspect, the cap assembly includes a threaded cap which isrotatably attached to the exterior of the proximal end of the side armbody and a funnel cap attached to the threaded cap.

In another aspect, a bleed back control seal in accordance with oneaspect of the invention has a cylindrical body with a lumen, a web areacovering a cross-section of the lumen and having a dilatable aperture,and the cylindrical body and web area are formed of an elastomer.

In another related aspect, the seal assembly further comprises a clampseal with a cylindrical body tapering to a frustum, with a lumen throughthe cylindrical body and frustum, and the clamp seal is formed of anelastomer.

In another aspect, a side arm body in accordance with another aspect ofthe invention has a proximal end and means for sealing connected to theproximal end of the side arm body, where the means for sealing comprisesmeans for controlling bleed back during use.

In a related aspect, a method in accordance with another aspect of theinvention for controlling blood loss using a bleed back control assemblyincludes introducing a vascular intervention device (such as, but notlimited to, a catheter) transluminally within the assembly, and forminga bleed back control seal around the introduced vascular interventiondevice.

Accordingly, with these and other apparatus and method aspects of theinvention, a bleed back control assembly in accordance with one aspectof the present invention controls blood loss during insertion, movement,and removal of a vascular intervention device (such as catheter) fromthe assembly. The user can adjust a clamp seal to clamp a vascularintervention device introduced transluminally, such as a catheter, tomaintain device position or perform high pressure injections. The usercan also close the clamp seal, without a vascular intervention deviceintroduced transluminally, to allow high pressure injections into theside arm body.

These and other aspects of the invention are described further below.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1a is a cross-sectional view of a side arm body in accordance withthe present invention. FIG. 1b is a cross-sectional view of a side armbody and seal assembly in accordance with the present invention.

FIG. 1c is a cross-sectional view of a side arm body, a seal assembly,and a cap assembly in accordance with the present invention. FIG. 1d isa cross-sectional view of a bleed back control assembly in accordancewith the present invention.

FIG. 2 is an exploded view of a seal body and side arm body of a bleedback control assembly in accordance with the present invention.

FIG. 3 is a cross-sectional view of a seal body and a proximal end of aside arm body of a bleed back control assembly in accordance with thepresent invention.

FIG. 4a is an exploded view and FIG. 4b is a cross-sectional view of aside arm body and male luer connector in accordance with the presentinvention.

FIG. 5a is a cross-sectional view and FIG. 5b is a perspective view ofbleed back control seal in accordance with the present invention. FIG.5c is a perspective view of a web area of a bleed back control seal inaccordance with another embodiment of the present invention. FIG. 5d isa cross-sectional view of a bleed back control seal in accordance withanother embodiment of the present invention.

FIG. 6a is a cross-sectional view and FIG. 6b is a perspective view of aseal holder in accordance with the present invention.

FIG. 7a is a cross-sectional view and FIG. 7b is a perspective view of aclamp seal in accordance with the present invention.

FIG. 8 is a cross-sectional view of a combined bleed back control sealand clamp seal in accordance with another embodiment of the presentinvention.

FIG. 9a is a side view, FIG. 9b is a cross-sectional view, and FIG. 9cis a top view of a threaded cap in accordance with the presentinvention.

FIG. 9d is a cross-sectional view and FIG. 9e is a perspective view of asnap retainer in accordance with the present invention. FIG. 9f is across-sectional view of a snap retainer and threaded cap in accordancewith the present invention.

FIG. 10a is a side view, FIG. 10b is a cross-sectional view, and FIG.10c is a top view of a funnel cap in accordance with the presentinvention.

FIGS. 11a to 11 e are a cross-sectional view of an operation of a clampseal in accordance with the present invention.

FIGS. 12a to 12 d are a cross-sectional view of an operation of a clampseal clamping a vascular intervention device (such as a catheter) whichhas been inserted transluminally in a bleed back control assembly inaccordance with the present invention.

FIGS. 13a to 13 d are a cross-sectional view of an operation of a funnelcap and dilator in relation to a bleed back control seal in accordancewith the present invention.

FIGS. 14a to 14 e are a cross-sectional view of an insertion of avascular intervention device (such as a catheter) through a bleed backcontrol seal in accordance with the present invention.

FIGS. 15a to 15 d are a cross-sectional view of an insertion of avascular intervention device (such as a catheter) through a dilatedbleed back control seal in accordance with the present invention.

DETAILED DESCRIPTION

Referring to FIGS. 1a through 1 d, the components of a bleed backcontrol assembly 1 in accordance with one aspect of the invention areshown in relation one to the other.

Referring to FIG. 1a, a side arm body 10 has a proximal end 12 with aseal cavity 14 formed therein. Side arm body 10 also has a distal end16. Side arm body 10 has a primary branch 11 and a secondary branch 13.A primary lumen 18 is formed through primary branch 11 of side arm body10 and connects proximal end 12 to distal end 16. Side arm body 10 isthus a tube having a lumen allowing fluid (such as blood) to communicatefrom one end to the other. Fluid may also communicate between lumen 18and seal cavity 14. A secondary lumen 15 is formed through secondarybranch 13 of side arm body 10. Fluid may also communicate between lumen18 of primary branch 11 and lumen 15 of secondary branch 13.

Referring to FIG. 1b, a seal assembly 20 is held within seal cavity 14at the proximal end 12 of side arm body 10. Seal assembly 20 isgenerally formed to conform to the shape and interior surface 23 of sealcavity 14. As discussed further below, seal assembly 20 comprises one ormore seals made of elastic and resilient materials which may be readilydeformed or stretched depending on user operation, and these seals willreturn to their original shape and position when released or disengaged.

Referring to FIG. 1c, cap assembly 30 is connected to seal assembly 20and is also connected to the exterior surface of seal cavity 14 at theproximal end 12 of side arm body 10. Cap assembly 30 contains sealassembly 20 within seal cavity 14 and, as described further below,allows user operation and adjustment of seal assembly 20. As describedfurther below, the user may adjust seal assembly 20 to either open orclose access to primary lumen 18 of side arm body 10, as well as clampvascular intervention devices introduced into bleed back controlassembly 1 to maintain device position or location. Seal body 40comprises seal assembly 20 and cap assembly 30. As shown in FIG. 1c, ableed back control assembly 1 in accordance with one aspect of theinvention comprises side arm body 10 connected to seal body 40 atproximal end 12 of side arm body 10.

Referring to FIG. 1d, another embodiment of bleed back control assembly1 in accordance with the invention comprises side arm body 10 having aproximal end 12 and a distal end 16. A seal body 40, comprising sealassembly 20 connected to cap assembly 30, is attached to proximal end 12of side arm body 10. Seal body 40 is a seal mechanism which includes oneor more elastomeric seals and cap assembly 30 to retain these sealswithin seal cavity 14. Seal assembly 20 has an aperture 22 formedtherethrough, and cap assembly 30 has an aperture 32 which is axiallyaligned with and proximal to seal assembly 20's aperture 22. Sealassembly 20's aperture 22 is also axially aligned with and proximal toprimary lumen 18.

A male luer connector 50 which is 360 degrees rotatable is connected todistal end 16 of side arm body 10. Luer connector 50 has a lumen 52which connects proximally with the distal end 16 of primary lumen 18 ofside arm body 10.

In general, a user may operate bleed black control assembly 1 byinserting a vascular intervention device (such as a catheter) throughaperture 32, then through aperture 22, into lumen 18, through lumen 52,and ultimately into a patient's body. A user may operate cap assembly 30by either pressing, screwing, or unscrewing cap assembly 30. Byoperating cap assembly 30, a user may open or close seal assembly 20 andthereby either seal the connection between aperture 22 and lumen 18 or,when a vascular intervention device is introduced into bleed backcontrol assembly 1, by clamping such a vascular intervention device byconstricting a portion of aperture 22 of seal assembly 20. Because ofseal assembly 20's elastomeric properties, seal assembly 20 providescontrol over blood loss during insertion and removal of vascularintervention devices through bleed back control assembly 1, as describedfurther below.

Referring to FIGS. 1a to 10 c, the structures of side arm body 10 andseal body 40 are shown. Side arm body 10 will be discussed first.

Side Arm Body

Referring to FIGS. 1a to 1 d, 2, 4 a, and 4 b, side arm body 10 issubstantially Y shaped and consists of a straight primary branch 11 anda secondary branch 13. Lumens 15 and 18 are formed within both thesecondary branch 13 and primary branch 11, respectively.

Lumen 15 of secondary branch 13 provides access to, and is in fluidcommunication with, lumen 18 of primary branch 11. Secondary branch 13can be used for, but is not limited to, contrast injections and drugdelivery. For example, secondary branch 13 may also be used for flushingthe system with saline, or any other appropriate uses. Secondary branch13 of side arm body 10 is formed, in one embodiment, at approximately a60 degree angle from primary branch 11. The invention is not limited bythe angle at which secondary branch 13 connects with primary branch 11.A port 17 is formed at the end of secondary branch 13, and this port 17provides connections for injections and other drug or fluid deliverydevices.

Referring to FIGS. 1a to 1 d, 2, and 4 a, a finger rest 19 is formed onthe exterior surface of secondary branch 13. Finger rest 19 is formed,in one embodiment, at approximately 30 degrees from secondary branch 13.In another embodiment, the angle at which finger rest 19 is formed maybe 20 degrees, 40 degrees, or any other suitable angle. The invention isnot limited by the angle at which finger rest 19 connects with secondarybranch 13. Finger rest 19 is sufficiently large enough to fit at leastone finger of an adult user of bleed back control assembly 1. Fingerrest 19 provides the user with improved gripping of bleed back controlassembly 1, particularly when the user is operating cap assembly 30 asdiscussed further below.

In another embodiment, a finger rest 19 is formed on the exteriorsurface of primary branch 11 of side arm body 10. In this embodiment,the finger rest 19 on primary branch 11 may be either in place of, or inaddition to, a finger rest 19 on secondary branch 13 of side arm body10.

Primary branch 11 of the side arm body 10 has two ends: a proximal end12 and a distal end 16. A seal cavity 14 is formed within proximal end12 of primary branch 11 of side arm body 10. Seal cavity 14 isconcentric with, and provides access to, lumen 18 formed axially throughprimary branch 11.

Seal cavity 14 has a wider diameter than the diameter of lumen 18. Inone embodiment, seal cavity 14's diameter is approximately 325% widerthan the diameter of lumen 18. The invention is not limited by thedifference between the diameters of seal cavity 14 and lumen 18.

In another embodiment, lumens 15 and 18 may taper or change diametersalong their lengths. In one embodiment, the diameter of lumen 18 towardsthe proximal end of lumen 18 may be approximately 16% wider than thediameter at the distal end of lumen 18. The invention is not limited bywhether lumens 15 or 18 taper, or by the amount by which each or eitherlumen tapers.

The exterior surface of seal cavity 14 has threads 21 to allow capassembly 30 to rotatably connect to side arm body 10, as describedfurther below.

Referring to FIGS. 1a, 2, 4 a, and 4 b, seal cavity 14 has an interiorsurface 23 which is adjacent to aperture 29 connecting seal cavity 14 tolumen 18.

In one embodiment as shown in FIGS. 2 and 4a, attached to interiorsurface 23 of seal cavity 14 is snap insert 25. As discussed furtherbelow in relation to FIGS. 3 and 11a to 11 e, blocking notch 27 of snapinsert 25 constrains the movement of seal assembly 20 within seal cavity14 and inhibits the removal of seal assembly 20 from seal cavity 14. Inan alternative embodiment, snap insert 25, including blocking notch 27,is integral with and formed as part of interior surface 23 of sealcavity 14.

Referring to FIGS. 4a and 4 b, distal end 16 of side arm body 10 isconnected to a male luer connector 50. Luer connector 50 has a lumen 52which connects proximally with the distal end of lumen 18. Male luerconnector 50 may be 360 degrees rotatable or any other appropriateamount of rotation.

In one embodiment, an O-ring 29 is interposed at the connection betweendistal end 16 of side arm body 10 and luer connector 50. O-ring 29improves the seal between side arm body 10 and luer connector 50.

O-ring 29 is a conventional O-ring gasket or seal formed of anappropriate elastic material. In one embodiment, O-ring 29 is formed ofblack color ethylene propylene diene monomer having a hardness of 70±5Shore-A, with an interior diameter of approximately 0.176 inches. IfO-ring 29 requires cleaning, a medical grade wash is used. O-ring 29 maybe non-cytotoxic, and in an alternate embodiment may be non-allergenic.

An appropriate lubricant may be used with O-ring 29. Dow Corning 360Medical Fluid, 350 centistoke viscosity (referred to as “Dow 360”) maybe used as a lubricant. In one embodiment, a mixture of alcohol and Dow360 may be used as a lubricant for O-ring 29. Alternatively, O-ring 29may be lubricated with a coating of a mixture of alcohol anddichloromethane followed by a successive coating of a mixture ofalcohol, dichloromethane, and Dow 360.

While a luer connector 50 is shown connected to the distal end 16 ofside arm body 10, the invention is not limited by whether any structuresare connected to distal end 16 nor by what those structures are. Thoseof ordinary skill will appreciate that other appropriate devices may beconnected to distal end 16 of side arm body 10 without departing fromthe scope of the invention. In an alternate embodiment, luer connector50 is formed integrally as part of distal end 16 of side arm body 10.

Side arm body 10, snap insert 25, and luer connector 50 may be formed ofany appropriate polymeric material (either thermoplastic orthermosetting). In one embodiment, side arm body 10, snap insert 25, andluer connector 50 are formed of polycarbonate, and may be formed ofradiation grade or e-beamable polycarbonate.

The invention is not limited by the type of O-ring 29 or connector 50used, nor by the type of lubricant used for O-ring 29.

Seal Body

Referring to FIGS. 1c and 1 d, seal body 40 comprises seal assembly 20connected to cap assembly 30, and cap assembly 30 is connected to theexterior surface of seal cavity 14. As discussed above, seal assembly 20is held within seal cavity 14 and conforms to the shape of the interiorsurface 23 of seal cavity 14. Cap assembly 30 holds seal assembly 20within seal cavity 14 and, as discussed below with respect to FIGS. 2, 4a, and 4 b, cap assembly 30 is connected to the proximal end of side armbody 10. Thus, seal body 40 is a seal mechanism connected to proximalend 12 of side arm body 10 as further described below.

Referring to FIG. 2, seal assembly 20 comprises bleed back control seal70, and seal holder 80. In another embodiment, seal assembly 20comprises a clamp seal 60, along with bleed back control seal 70 andseal holder 80. Cap assembly 30 comprises funnel cap 90, threaded cap100, return spring 110, and snap retainer 120. Thus, seal body 40 is aseal mechanism comprising one or more seals, such as bleed back controlseal 70, as well as seal holder 80, and two caps, funnel cap 90 andthreaded cap 100, as well as spring 110 and snap retainer 120.

FIG. 2 shows these components in exploded view, and FIG. 3 shows thesecomponents assembled in relation to each other, as well as in relationto the proximal end 12 of side arm body 10. In the orientation of FIG.3, the proximal end of the seal body 40 is shown at the top of thefigure. Each component will be discussed in turn.

a. Clamp Seal

Referring to FIGS. 2, 3, 7 a and 7 b, clamp seal 60 is shaped as threesuccessively larger concentric cylinders, comprising cylindricalportions 63, 65, and 67, with a frustrum portion 61 connected distallyto cylindrical portion 63. The cylindrical portion 63 thus tapers at thedistal end to a frustum portion 61. Clamp seal 60 fits within sealcavity 14 and conforms generally to the diameter and shape of the bottomof interior surface 23 of seal cavity 14. In one embodiment, there maybe a gap or space between clamp seal 60 and the distal interior portion23 of seal cavity 14, when clamp seal 60 has not been closed or operatedon by the user. Clamp seal 60 has a lumen 62 formed through thecylindrical portions 63, 65, and 67, as well as frustum portion 61.Lumen 62 is in fluid communication with lumen 18 of side arm body 10.

In one embodiment, the maximum diameter of distal cylindrical portion 63(as well as the diameter of the bottom frustum portion 61) of clamp seal60 is larger than the interior diameter of the corresponding portion ofseal cavity 14. In addition, the maximum diameter of proximalcylindrical portion 67 of clamp seal 60 is larger than the interiordiameter of the corresponding portion of distal seal holder cavity 85 ofseal holder 89. The invention is not limited by the precise differentialbetween the diameters of clamp seal 60 and the interior diameter of sealcavity 14 or distal seal holder cavity 85. This difference in diametersresults in the walls of seal cavity 14 providing compression and supportto the distal cylindrical portion 63 of clamp seal 60, and ensures thatdistal cylindrical portion of clamp seal 60 provides a seal inhibitingfluids or gases from escaping around the distal outside surface of sealclamp 60. In addition, the difference in diameters between proximalcylindrical portion 67 of clamp seal 60 and distal seal holder cavity 85results in the walls of distal seal holder cavity 85 providingcompression and support to clamp seal 60, and ensures that cylindricalportion 67 inhibits fluids or gases from escaping around the proximalexterior surface of clamp seal 60.

As discussed below in relation to FIGS. 11a to 11 e, a user may open andclose clamp seal 60 by turning threaded cap 100. Thus, clamp seal 60 maybe opened and closed selectively. In its open, disengaged position,clamp seal 60 creates a seal inhibiting the flow of fluids or gases intoseal body 40 other than through lumen 62 of clamp seal 60. Clamp seal 60also acts as a bridge or transition joint between seal body 40 and sidearm body 10.

As discussed, clamp seal 60 has a lumen 62 formed axially therethroughwhich is concentric with lumen 18 of side arm body 10. Lumen 62 taperssuch that the top (or proximal) aperture of lumen 62 has a smallerdiameter than the bottom (or distal) aperture of lumen 62. In oneembodiment, the top aperture of lumen 62 is approximately 85% as wide asthe bottom aperture of lumen 62. The bottom aperture of lumen 62 has aslightly larger diameter than the diameter of aperture 29 connecting tolumen 18 of primary shaft 11 of side arm body 10. In one embodiment, thebottom aperture of lumen 62 of clamp seal 60 has a diameter larger thanthe diameter of aperture 29 leading to lumen 18 of side arm body 10.Also, the proximal aperture of lumen 62 of clamp seal 60 has a diameterlarger than the diameter of aperture 82 of seal holder 80. Thesedifferences in diameters provide rebound so that clamp seal 60 does notget stuck in lumen 18 or in aperture 82 of seal holder 80.

The interior surface 23 of seal cavity 14 and the tapered frustum 61 ofclamp seal 60 are, in this embodiment, both at approximately a 20 degreeangle from the plane of the distal (or bottom) aperture of lumen 62.Those of ordinary skill will appreciate that the invention is notlimited by the angle of either interior surface 23 or clamp seal 60'sfrustum portion 61, nor by the amount of taper in lumen 62.

Clamp seal 60 is formed of an elastic and resilient material, such as anappropriate elastomeric substance. In one embodiment, clamp seal 60 ismade of black color fluorosilicone having a hardness of 35±5 Shore-A.Clamp seal 60 is, in this embodiment, post cured for 4 hours at 400degrees Fahrenheit. Clamp seal 60 may be cleaned by any conventionalmethod known to those of ordinary skill, if needed. Additionally, soapwater may be used as a mold release prior to cleaning, if any. Ifcleaning is performed, a 50/50 mixture of alcohol and deionized watermay be used. If clamp seal 60 is formed of a synthetic ductile material,clamp seal 60 may be non-allergenic, and in an alternate embodiment maybe non-cytotoxic.

An appropriate lubricant may be used with clamp seal 60. Dow 360 byitself may, however, exhibit some adhering properties within lumen 62 ofclamp seal 60 over time or at an elevated temperature. In oneembodiment, a mixture of alcohol and Dow 360 may be used as a lubricantfor clamp seal 60, and this mixture may bond to some extent to thesurface of clamp seal 60. Alternatively, clamp seal 60 may be lubricatedwith a coating of a mixture of alcohol and dichloromethane, followed bya successive coating of a mixture of alcohol, dichloromethane, and Dow360. The invention is not limited by the type (or presence) of lubricantused for clamp seal 60.

In one embodiment, clamp seal 60 forms part of seal assembly 20. Inanother alternate embodiment, seal assembly 20 does not include clampseal 60. One of ordinary skill will understand that, in this embodiment,the absence of seal clamp 60 may result in minor alterations in sealholder 80 or cap assembly 30.

b. Seal Holder

Referring to FIGS. 2, 3, 6 a, and 6 b, within seal body 40 seal holder80 is placed between clamp seal 60 and bleed back control seal 70. Sealholder 80 has an aperture 82 formed in its bottom surface, and thisaperture 82 is concentric with lumen 62 of clamp seal 60. In oneembodiment, aperture 82 of seal holder 80 has a diameter smaller thanthe diameter of the proximal (or top) aperture of lumen 62 of clamp seal60.

Seal holder 80 terminates distally with bottom arms 84. Arms 84 conformsubstantially with the shape of the proximal surface 64 of clamp seal60. As described below, arms 84 of seal holder 80 provide axial andradial compression to clamp seal 60.

As discussed above, seal holder 80 has a distal seal holder cavity 85formed distal to aperture 82 and defined by the distal portion of arms84. As discussed above, proximal cylindrical portion 67 of clamp seal 60is set within distal seal holder cavity 85.

Referring to FIG. 6a, horizontal legs 86 extend laterally from arms 84.Legs 86 form the proximal wall of distal seal holder cavity 85.Referring to FIGS. 2 and 3, legs 86 of seal holder 80 are interposedbetween the proximal surface 64 of clamp seal 60 and the distal arms 76of bleed back control seal 70.

Risers 87 are formed at the ends of legs 86 and protrude proximally.Legs 86 and risers 87 are formed so that aperture 82 is formedtherethrough. The distal (or bottom) surface of legs 86 conformsubstantially with the shape of the proximal (or top) surface 64 ofclamp seal 60. The proximal (or top) surface of legs 86 support andconform substantially to the distal (or bottom) surface of distalportion 77 of arms 76 of bleed back control seal 70. In one embodiment,distal portions 77 may bevel inward as shown for example in FIGS. 2 and3. Risers 87 prevent compression of distal portions 77 of bleed backcontrol seal 70 into aperture 82.

Seal holder 80 has a proximal interior chamber 88 which is defined bywalls 89. Interior chamber 88 is in fluid communication with lumen 62 ofclamp seal 60, by virtue of aperture 82. Bleed back control seal 70 issupported within interior chamber 88. The diameter of top or proximalinterior chamber 88 is slightly smaller than the diameter of bleed backcontrol seal 70. Accordingly, walls 89 of seal holder 80 provide axialand radial support, as well as compression (axial and radial), for bleedback control seal 70. In one embodiment, the diameter of top or proximalinterior chamber 88 is approximately 6% smaller than the diameter ofbleed back control seal 70. The invention is not limited by a preciseratio of the diameters of interior chamber 88 of seal holder 80 andbleed back control seal 70.

c. Bleed Back Control Seal

Referring to FIGS. 2, 3, 5 a, 5 b, and 5 c, bleed back control seal 70has distal (or bottom) side arms 76, a web area 72 formed between arms76, distal portions 77 of arms 76, and upper ears 78. Bleed back controlseal 70 is, in one embodiment, substantially in the shape of twoconcentric cylinders each having a lumen, with a bottom (or distal)chamber 73 divided from a top (or proximal) chamber 75 by web area 72.Web area 72 is formed at the proximal or top end of chamber 73 of thelarger, bottom (or distal) cylinder formed by side arms 76. The diameterof the top cylinder formed by ears 78 is smaller than the diameter ofthe bottom cylinder formed by side arms 76. In one embodiment, chamber73 formed between side arms 76 has a diameter larger than the diameterof chamber 75 formed between ears 78.

As discussed further below in relation to FIGS. 3 and 13a to 13 d,funnel cap 90 comprises a dilator 92 which is a tube having a lumenextending from the proximal end of funnel cap 90 to top chamber 75 ofbleed back control seal 70. Dilator 92's distal end is held within topchamber 75 of bleed back control seal 70, unless dilator 92 is moved. Asdiscussed further below, the user can move dilator 92 distally, and thuscause bleed back control seal 70 to dilate or open. However, in theunactivated or normal state, dilator 92 rests close to, but does notimpact, web area 72 of bleed back control seal 70.

Ears 78 of bleed back control seal 70 are shaped to conform with thediameter and shape of dilator 92. The ears 78 of bleed back control seal70 have an interior diameter smaller than the exterior diameter ofdilator 92. This difference in diameters ensures that ears 78 provide aseal and inhibit fluids or gases from escaping proximally around theexterior surface of dilator 92. The proximal end of ears 78 are formedto surround dilator 92 when dilator 92 is in both its disengaged andengaged positions. Ears 78 will surround and seal around the exterior ofdilator 92 when threaded cap 100 is screwed down or tightened (asdiscussed below in relation to FIGS. 11a to 11 e, screwing or tighteningthreaded cap 100 has the effect of moving both bleed back control seal70 and seal holder 80 distally). Thus, ears 78 of bleed back controlseal 70 form a seal around the exterior surface of dilator 92 regardlessof how the user manipulates cap assembly 30.

In one embodiment, the proximal end of ears 78 may be notched at anangle of approximately 30 degrees to improve seal integrity and aid inalignment of dilator 92 of funnel cap 90. Thus, integrated into bleedback control seal 70 is a seal formed by ears 78 surrounding dilator 92in order to prevent or inhibit fluid or gas leakage into interiorchamber 94 of funnel cap 90.

Bleed back control seal 70 may thus inhibit the introduction of fluidsor gases into interior chamber 94 of funnel cap 90. For some users ofbleed back control assembly 1, in some circumstances, it may beundesirable to allow blood or other fluid to enter interior chamber 94of funnel cap 90, because of a potential increased risk of confusion asto whether bleed back control assembly 1 is leaking. Fluid leakage intointerior chamber 94 of funnel cap 90 may also make it more difficult toengage or depress funnel cap 90 so as to move dilator 92, as discussedbelow. Finally, if blood or other fluid were to collect in interiorchamber 94 of funnel cap 90, trapped fluid may leak or spurt out offunnel cap 90 when the user depresses or engages funnel cap 90.

As noted above, bleed back control seal 70 has a web area 72 dividingtop chamber 75 from bottom chamber 73. Web area 72 is roughlyperpendicular to the plane of ears 78 and is located distal to ears 78.Web area 72 may be regarded as both the floor of top chamber 75 and theceiling of bottom chamber 73 of bleed back control seal 70. As shown inFIG. 5b, web area 72 is substantially disc shaped.

Web area 72 is thinner at the center and thicker towards the side arms76. In one embodiment as shown for example in FIGS. 2, 3, and 5 a, thecross-section of web area 72 is approximately wedge shaped. A wedgeshaped cross-section of web area 72 provides support for seal integrity.In one embodiment, the wedge may be formed at an angle of approximately115 degrees from the plane of side arms 76. However, one of ordinaryskill would appreciate that the angle of the wedge may differ, and theinvention is not limited by the precise angle of the wedge.

The thinning of web area 72 towards the center provides a balancebetween sealing and ease of vascular intervention device movementthrough web area 72. This change in thickness of web area 72 alsoresists tearing of web area 72 as a vascular intervention device isinserted through web area 72. In one embodiment, web area 72 thins atthe middle to a width of approximately 0.023 to 0.031 inches. Theinvention is not limited by the exact width of web area 72 or the angleof the wedge cross-section of web area 72.

In the center of web 72 is aperture 74. In one embodiment, aperture 74is formed as a pinhole completely intersecting web area 72. Aperture 74is concentric with lumen 18 of the primary shaft 11 of side arm body 10,as well as lumen 62 of clamp seal 60. As noted above, the user may pushfunnel cap 90 and dilator 92 distally. By moving dilator 92 distally, auser will cause dilator 92 to stretch the elastomeric material of webarea 72, thus causing aperture 74 to dilate or open wider.

In the normal, disengaged position, in which dilator 92 does not impactweb area 72, aperture 74 of bleed back control seal 70 is closed andinhibits the passage of fluid through bleed back control seal 70. In theclosed position, bleed back control seal 70's web area 72 inhibits fluidcommunication between bottom chamber 73 and top chamber 75. Ultimately,in the closed or normal position, web area 72 of bleed back control seal70 inhibits bleed back or loss of fluid from primary lumen 18 to dilator92 of funnel cap 90.

In the closed position, bleed back control seal 70 can withstand fluidpressures of roughly 40-100 psi. The invention is not limited by theprecise fluid pressures which bleed back control seal 70 may withstand.The resistance of bleed back control seal 70 to fluidic pressure may beincreased depending on the elastic material used for forming bleed backcontrol seal 70 or on the dimensions of seal 70, including thickness ofweb area 72 and precise configuration of aperture 74.

In an alternate embodiment, web area 72 may have an aperture 74 whichmay be formed with slits 71 and flaps 79 in a star or tricuspid shape asshown in FIG. 5c. By using this star shaped embodiment of aperture 74,bleed back control seal 70 may increase resistance to fluid pressures upto approximately 500 psi.

In an alternate embodiment, web area 72 may include a spherical portion79 connected in the center of the distal surface of web area 72, asshown in FIG. 5d. In this embodiment, aperture 74 extends throughspherical portion 79. By using this spherical portion 79 as a pressuredome, bleed back control seal 70 may then ease resistance to fluidpressures to approximately 400 psi.

Bleed back control seal 70 extends distally with arms 76. Arms 76 havedistal portions 77. In one embodiment, distal portions 77 may bevelinward, and the invention is not limited by the amount or presence ofbevel of distal portions 77. As discussed above, the proximal surface oflegs 86 of seal holder 80 support the bottom or distal portions 77 ofbleed back control seal 70. Legs 86 terminate in risers 87. The proximalsurface of legs 86 are shaped to conform substantially to and engagewith the distal surface of distal portions 77 of arms 76 of bleed backcontrol seal 70. Risers 87 prevent compression of distal portions 77 ofbleed back control seal 70 into aperture 82 of seal holder 80. Legs 86and risers 87 of seal holder 80 also provide rigidity, support, andcompression to bleed back control seal 70. Bleed back control seal 70 isheld within chamber 88 formed by legs 86, risers 87, and walls 89 ofseal holder 80.

Bleed back control seal 70 is made from a suitably elastic polymericmaterial. In one embodiment, bleed back control seal 70 is made ofnatural yellowish color polyisoprene having a hardness of 30±5 Shore-Aand elongation of approximately 750%. In another embodiment, bleed backcontrol seal 70 may be formed of a synthetic latex, silicone, or rubber.Bleed back control seal 70 may be sterilized by conventional techniquessuch as e-beam or ethylene oxide sterilization. Bleed back control seal70 may be cleaned, if wanted, by any conventional cleaning method knownto those of ordinary skill. Bleed back control seal 70 is formed of asynthetic resilient material, and bleed back control seal 70 may benon-cytotoxic, and in an alternate embodiment may be non-allergenic.

Those of ordinary skill will understand that other elastic or resilientmaterials may be suitable for bleed back control seal 70. In oneembodiment, polyisoprene, manufactured by Lexington Medical, of 30durometer medical grade may be used.

The elasticity of the material of bleed back control seal 70 causes webarea 72 to form and seal around a vascular intervention deviceintroduced through dilator 92, then into top chamber 75, then throughaperture 74, and then through bottom chamber 73 of bleed back controlseal 70. Thus, bleed back control seal 70 is self-sizing and preventsfluid loss or bleed back, while still allowing movement of a vascularintervention device through bleed back control assembly 1. A user mayintroduce any appropriate vascular intervention device 130 into bleedback control assembly 1, such as a catheter (for example, a ballooncatheter, an atherectomy catheter, a guidewire, or a stent with deliverysystem). The elasticity of web area 72 and bleed back control seal 70generally allows a seal to form around any inserted devices 130. Bleedback control seal 70 is formed of an elastomer with elongation,resilience, and elasticity properties which are sufficient to allowdilation and constriction of bleed back seal 70, as well as insertion ofdevices 130 through aperture 74 of web area 70, without losing sealintegrity. For example, polyisoprene allows approximately 750%elongation.

Those of ordinary skill will appreciate that bleed back control seal 70can be of varying dimensions. For example, the diameter of bottomchamber 73 formed by side arms 76 and the angle of the wedgecross-section of web area 72 may be changed to improve efficiency. Thus,for example, increasing the diameter of bottom chamber 73 formed by sidearms 76 may facilitate movement of dilator 92 of funnel cap 90 ordevices 130 through the aperture 74 of bleed back control seal 70.

One of ordinary skill will appreciate that any suitable lubricant may beused for bleed back control seal 70. Surface tack may be removed by gaschlorinating at 800±100 parts per million. However, chlorinating mayaffect device movement or sealing through seal 70. Alternatively, apolydimethyl siloxane liquid lubricant may be used. In one embodiment,Dow 360, 350 centistoke viscosity, may be used as a lubricant.Alternatively, a coating of paralene may be used as a lubricant, or asuitable lubricant may be bonded into the surface of the material ofbleed back control seal 70. The invention is not limited by the type (orpresence) of lubricant used with bleed back control seal 70.

Referring to FIGS. 1d, 2, and 9 a through 9 c, within seal body 40, asnoted above, bleed back control seal 70 is held within interior chamber88 of seal holder 80 and is held distal to threaded cap 100. Interiorarms 101 of threaded cap 100 engage the proximal (or top) end of bleedback control seal 70, such as the exterior surface of ears 78. Interiorarms 101 of threaded cap 100 thus retain bleed back control seal 70 andkeep bleed back control seal 70 placed within interior chamber 88 ofseal holder 80.

In an alternate embodiment, interior arms 101 may be formed of anappropriate size and shape so as to provide rigidity and compression(either axial, radial, or both) to bleed back control seal 70, includingears 78.

Referring to FIG. 8, in an alternate embodiment, both clamp seal 60 andbleed back control seal 70 may be formed of one combined, integral sealstructure. This combined clamp seal 60 and bleed back control seal 70performs all the functions of these two seals all in one structure. Inthis embodiment, the combined clamp seal 60 and bleed back control seal70 may be formed of any suitable material, for example, 30 or 45durometer polyisoprene, fluorosilicone, silicone, or a blend of any of aplurality of appropriate resilient or elastic materials. In thisembodiment, threaded cap 100 and seal holder 80 may, but need not, becombined in one integrated structure as well.

Thus, seal assembly 20 of seal body 40 comprises, in one embodiment,clamp seal 60, bleed back control seal 70, and seal holder 80. Capassembly 30 of seal body 40 will be discussed next.

d. Funnel Cap, Dilator, and Return Spring

Cap assembly 30 comprises two concentric caps, funnel cap 90 andthreaded cap 100, as well as spring 110 and snap retainer 120. Funnelcap 90 is proximal to and envelops threaded cap 100. Funnel cap 90 andthreaded cap 100 may be any suitable approximately cylindrical shapes,and in one embodiment may be octagonal cylinders.

Referring to FIGS. 2, 3, and 10 a to 10 c, funnel cap 90 includesdilator 92 formed in the interior chamber 94 of funnel cap 90. Dilator92 has a lumen extending distally away from funnel surface 96 of funnelcap 90. Dilator 92 is concentric with lumen 18 of side arm body 10.Dilator 92 is thus a tube with a lumen connecting (at the proximal end)the exterior of bleed back control assembly 1 with the interior of topchamber 75 of bleed back control seal 70 (at the distal end). Funnel cap90 is proximal to bleed back control seal 70 and, in the disengagedposition, the distal end of dilator 92 is proximal to and slightlyseparated from web area 72 of bleed back control seal 70. Dilator 92'slumen, in one embodiment, does not taper or change diameter, but thoseof ordinary skill will appreciate that dilator 92's lumen may taper orwiden without departing from the scope of the invention.

Funnel cap 90 has a proximal exterior surface which tapers in the centerto form the shape of a funnel 96 leading into the lumen of dilator 92.Funnel 96 of funnel cap 90 is concentric with the lumen of dilator 92.The maximum diameter of funnel 96, in one embodiment, may beapproximately 73% of the diameter of the proximal surface of funnel cap90. The invention is not limited by the precise ratio of the diametersof the funnel 96 and proximal surface of funnel cap 90. Funnel 96improves the loading or self-locating of guidewires, catheters, andother devices 130 as the operator seeks to introduce them into bleedback control assembly 1. In one embodiment, funnel 96 may be formed atapproximately a 25 degree angle from the plane of proximal surface offunnel cap 90. The invention is not limited by the angle at which funnel96 is formed, nor by the diameter of funnel 96 as compared to thediameter of funnel cap 90.

Surrounding dilator 92 and disposed within interior chamber 94 of funnelcap 90 is return spring 110. The ends of spring 110 are squared. In oneembodiment, spring 110 may have a spring rate of approximately 3.9lbs./inch.

The proximal end of spring 110 abuts the interior surface of theproximal end of funnel cap 90. In one embodiment, the distal end ofspring 110 abuts proximal surface 104 of threaded cap 100. In anotherembodiment, as discussed below, the distal end of spring 110 abuts andsits within proximal bowl 124 of snap retainer 120. In this embodiment,the placement of the distal end of spring 110 in bowl 124 helpsstabilize and align spring 110, while spring 110 helps keep snapretainer 120 in place. In an alternate embodiment, the proximal surfaceof seal holder 80 may be formed to abut and support the distal end ofspring 110.

The windings or coils of spring 110 surround the exterior surface ofdilator 92. In one embodiment, spring 110 may have approximately fivewindings or coils. The invention is not limited by the diameter orspacing or number of the windings of spring 110. Spring 110 acts toreturn funnel cap 90 to the original or normal position when released,so that dilator 92 will not dilate aperture 74 of bleed back controlseal 70 when the user releases funnel cap 90.

Spring 110 may be of any suitable material, and in one embodiment may beformed of 302 stainless steel wire. In one embodiment, the wire ofspring 110 is approximately 0.018 inches in diameter, each winding ofspring 110 is approximately 0.24 inches in diameter, and spring 110 isapproximately 0.5 inches long in its uncompressed state. Spring 110 hasends which may be squared. The invention is not limited by the materialout of which spring 110 is formed.

Funnel cap 90's exterior surface extends distally and terminates in arms98. In an embodiment in which funnel cap 90 is octagonal, funnel cap 90has eight arms 98. Overhanging lip 99 is formed at the distal edge orbottom of arms 98, and overhang 99 extends generally inward towards theinterior chamber 94 of funnel cap 90. Overhang 99 of funnel cap 90 gripsthe distal surface of threaded cap 100 and thereby attaches funnel cap90 to the exterior of threaded cap 100. Overhang 99 prevents funnel cap90 from disengaging from threaded cap 100 by wrapping around the distalor bottom edge of threaded cap 100. Additionally, the arrangement ofoverhang 99 with threaded cap 100 allows funnel cap 90 to be moveddistally, thus allowing dilator 92 to move distally as well throughthreaded cap 100 and bleed back control seal 70. Additionally, thearrangement of overhang 99 with threaded cap 100 allows funnel cap 90 toretain spring 110 in position, which in turn allows snap retainer 120 tobe aligned and held in position. Additionally, the arrangement of funnelcap 90 with threaded cap 100 allows spring 110 to be held in acompressible manner, so as to allow spring 110 to return funnel cap 90to its original or normal position after being released. The inventionis not limited by the number of arms 98 or the shape of overhang 99, noris the invention limited by the manner by which funnel cap 90 isconnected to threaded cap 100.

e. Threaded Cap and Snap Retainer

Referring to FIGS. 2, 3, and 9 a to 9 c, in seal body 40 threaded cap100 is interposed between funnel cap 90 and seal holder 80. Threaded cap100 has a diameter such that threaded cap 100 fits the shape of theinterior chamber 94 of funnel cap 90, and thus threaded cap 100 willconform inside funnel cap 90. The exterior surface of threaded cap 100is, in one embodiment, octagonal, and similarly, in this embodiment, theinterior surface of funnel cap 90 is octagonal as well. This arrangementallows a user to screw or twist threaded cap 100 by screwing or twistingthe funnel cap 90, which thus results in axial movement of seal holder80 and resulting compression or relaxation of clamp seal 60. Similarly,the arrangement of threaded cap 100 and funnel cap 90 allows funnel cap90 to be moved by a user distally and proximally in an axial directionover the exterior surface of threaded cap 100, which thus results inaxial movement of dilator 92 and resulting dilation or constriction ofbleed back control seal 70.

Threaded cap 100 has a center hole 102 formed in its proximal surface104. Threaded cap 100's center hole 102 has a diameter slightly widerthan the diameter of dilator 92, and threaded cap 100's center hole 102is concentric with the lumen of dilator 92. The distal end of dilator 92of funnel cap 90 extends axially through center hole 102 of threaded cap100.

Threaded cap 100 also has interior arms 101 which surround the centerhole of threaded cap 100. Referring to FIG. 3, interior arms 101 areformed to conform to the shape of ears 78 and the proximal end of bleedback control seal 70.

Threaded cap 100 has secondary slots or apertures 106 formed in proximalsurface 104 to allow seal holder 80 to attach to threaded cap 100. Inone embodiment, there are three secondary apertures 106 which are shapedas curved slots and are spaced approximately equidistantly from eachother around the same circumference. The proximal end of seal holder 80ends in arms 81 which extend through secondary apertures 106 of threadedcap 100. Arms 81 have jaws which grip and envelop the portions ofproximal surface 104 adjacent to secondary apertures 106. Arms 81 ofseal holder 80 thus engage and connect to proximal surface 104 ofthreaded cap 100.

In one embodiment, a snap retainer 120 may be connected to threaded cap100. In this embodiment, snap retainer 120 is connected to, and proximalto, threaded cap 100. Snap retainer 120 has a center hole 126 formed inits surface. Hole 126 of snap retainer 120 is concentric with centerhole 102 of threaded cap 104. The diameter of snap retainer 120's centerhole 126 is approximately equal to or greater than the diameter ofcenter hole 102 of threaded cap 100. Center hole 126 of snap retainer120 has a diameter greater than the maximum, exterior diameter ofdilator 92 of funnel cap 90. Dilator 92 thus extends distally throughcenter hole 126 of snap retainer 120 and then through center hole 102 ofthreaded cap 100. Referring to FIG. 9f, snap retainer 120 is concentricwith threaded cap 100, and has an exterior maximum diameter slightlysmaller than the diameter of the proximal portion of chamber 88 formedby arms 81 of seal holder 80. Snap retainer feet 122 of snap retainer120 have an interior diameter slightly greater than the interiordiameter of slots 106 of threaded cap 100, and thus feet 122 may fit inslots 106 behind arms 81 of seal holder 80. Snap retainer 120 also hasan interior diameter larger than the exterior diameter of dilator 92 offunnel cap 90.

Snap retainer 120 has feet 122 which protrude distally. Feet 122 areformed to fit within each of apertures 106 of threaded cap 100. In oneembodiment, there are three feet 122 which are curved and are spacedapproximately equidistantly from each other around the samecircumference. In another embodiment, feet 122 may be spaced from eachother approximately 112 degrees, 112 degrees, and 136 degrees apart, ifmeasured from midpoint to midpoint along their common circumference.Feet 122 are formed to fit within apertures 106 along with arms 81 ofseal holder 80. Feet 122 sit interior to arms 81, and thus providesupport to arms 81 and ensure that arms 81 retain a firm connection withsurface 104 of threaded cap 100.

Snap retainer 120 also includes a proximal bowl 124. The distal end ofreturn spring 110 sits within bowl 124 of retainer 120 without blockingthe movement of dilator 92 through center hole 126. In this embodiment,proximal bowl 124 stabilizes and aligns spring 110. In turn, spring 110holds snap retainer 120 in position atop threaded cap 100.

Threaded cap 100 has threads 108 formed in the interior surface ofthreaded cap 100. Threads 108 rotatably connect threaded cap 100 to sidearm body 10, by connecting with threads 21 formed on the exteriorsurface of seal cavity 14.

As noted above, an alternate embodiment may comprise a seal assembly 20which does not include clamp seal 60. In this alternate embodiment, sealholder 80 may be incorporated into proximal end 12 of side arm body 10.In this embodiment, snap retainer 120 and slots 106 of threaded cap 100may no longer be necessary. In this embodiment, threaded cap 100 neednot be rotatably attached to side arm body 10.

f. Miscellaneous

As shown in FIGS. 2, 3, and 9 f, funnel 96 of funnel cap 90, dilator 92,center hole 126 of snap retainer 120, center hole 102 of threaded cap100, aperture 74 in web area 72 of bleed back control seal 70, upperchamber 75 and lower chamber 73 of bleed back control seal 70, upperchamber 88 and distal cavity 85 and aperture 82 of seal holder 80, lumen62 of clamp seal 60, and aperture 29 and lumen 18 of side arm body 10are all substantially aligned along the same axis and are thus allessentially concentric.

Seal holder 80, funnel cap 90, threaded cap 100, and snap retainer 120are all made of any suitable polymeric material, similar to side armbody 10, snap insert 25, and luer connector 50. In one embodiment, sealholder 80, funnel cap 90, threaded cap 100, and snap retainer 120 may bemade of radiation grade polycarbonate.

Thus, the cap assembly 30 of seal body 40 comprises funnel cap 90,threaded cap 100, spring 110, and snap retainer 120. As discussed above,the user may operate cap assembly 30 to open or close seal assembly 20.The operation and interaction between cap assembly 30 and seal assembly20 will be discussed next.

Operation of Clamp Seal

As noted above, one embodiment comprises a seal assembly 20 which doesnot include clamp seal 60. In an alternate embodiment, such as shown inFIGS. 2 and 3, clamp seal 60 may be included. In this alternateembodiment, operation of clamp seal 60 may be controlled by the user.

In this embodiment, clamp seal 60 may be opened or closed by the user.In the open position, clamp seal 60 allows fluids (such as blood) topass through lumen 62 and will not impede the movement of devices (suchas a catheter) through lumen 62. In the closed position, clamp seal 60will substantially inhibit the flow of fluid (such as blood) throughlumen 62, thus sealing aperture 29 connecting seal body 40 and side armbody 10. If a device (such as a catheter) has already been insertedthrough lumen 62, closing clamp seal 60 will cause lumen 62 to clamparound that device and hold that device in place. Operation of clampseal 60 to open or close is discussed with reference to FIGS. 3, 11 a to11 e, and 12 a to 12 d.

As noted above, turning threaded cap 100 causes clamp seal 60 to openand close. Proximal to and abutting the proximal surface 64 of clampseal 60 is seal holder 80. Seal holder 80 has upper arms 81 whichconnect seal holder 80 to proximal surface 104 of threaded cap 100.Threaded cap 100 is rotatably connected to the exterior surface of sealcavity 14.

Threaded cap 100 may be rotated by the user to move threaded cap 100axially towards or away from the distal end 16 of side arm body 10.Rotating or adjusting threaded cap 100 causes seal holder 80 to moveaxially as well. Rotation of threaded cap 100 to move distally isreferred to as tightening, closing, or screwing of threaded cap 100;rotation of threaded cap 100 to move in the opposite, proximal directionis referred to as loosening, opening, or unscrewing threaded cap 100.

Rotating threaded cap 100 causes a corresponding axial movement of sealholder 80. When threaded cap 100 is tightened, the correspondingmovement of seal holder 80 will cause the distal end 84 of seal holder80 to compress seal clamp 60. Axial movement of seal holder 80 causes acorresponding compression (or closure) of clamp seal 60. A user'stightening of threaded cap 100 causes seal holder 80 to compress anddeform clamp seal 80, which is made of an elastic material.

When threaded cap 100 is tightened, clamp seal 60 may be closedcompletely, when there is no device introduced within lumen 62 of clampseal 60. As shown in FIGS. 11a to 11 e, as threaded cap 100 istightened, the material forming the walls of lumen 62 will deform andcollapse or constrict lumen 62. Sufficient tightening of threaded cap100 will cause the deformed frustum portion 61 of clamp seal 60 to enterand seal aperture 29 at the proximal end of lumen 18 of the primaryshaft 11 of side arm body 10. Sufficient tightening of threaded cap 100will also cause lumen 62 to constrict completely. Additionally,tightening of threaded cap 100 causes the cylindrical portions 63, 65,and 67 of clamp seal 60 to compress and deform, thus creating a sealaround the exterior surface of clamp seal 60 where it impacts theinterior walls of seal cavity 14. Thus, tightening threaded cap 100 willcause clamp seal 60 to close and inhibit the flow of fluid from side armbody 10 to the seal body 40.

Clamp seal 60 can be opened by unscrewing threaded cap 100. As threadedcap 100 and seal holder 80 are moved proximally, the resilientproperties of the elastic material of clamp seal 60 will cause clampseal 60 to return to its original shape and position.

Adjustment of threaded cap 100 to cause clamp seal 60 to close hasseveral advantages. For example, it is undesirable for injectionsintroduced through secondary branch 13 to exit side arm body 10 throughproximal end 12, because the injected fluid will not be delivered to thepatient. Closing clamp seal 60 allows the user to perform high pressureinjections through secondary branch 13 of side arm body 10 whileensuring that the injected fluid does not exit side arm body 10 throughproximal end 12. Typically, a user can generate up to approximately 200psi for manual injections. In the closed position, clamp seal 60 canwithstand up to at least approximately 400 psi, thus allowing the userto perform injections through lumen 15 of secondary branch 13 withoutallowing the fluid from these injections to exit side arm body 10 intoseal body 40. In this way, injections through secondary branch 13 willbe delivered into lumen 18 of primary branch 11 and then exit lumen 18through distal end 16, then through lumen 52 of luer 50, and ultimatelyinto the patient.

Referring to FIGS. 12a to 12 d, clamp seal 60 may also be closed ortightened when a device 130 (such as a catheter) is introducedintratubally within lumen 62 of clamp seal 60. Tightening of threadedcap 100 causes distal movement of seal holder 80 and causes radial andaxial compression of clamp seal 60. This compression causes constrictionof the diameter of lumen 62 of clamp seal 60, as shown in FIGS. 12b to12 d. As discussed above, a device 130 (such as a catheter) can beintroduced through funnel 96 and dilator 92 of funnel cap 90, throughaperture 74 of bleed back control seal 70, through aperture 82 of sealholder 80, and through and within lumen 62 of seal clamp 60, and furtherthrough aperture 29 and lumen 18 of side arm body 10. If a device 130has been introduced within lumen 62 of clamp seal 60, then thecompression of clamp seal 60 will cause lumen 62 to constrict about theshaft of device 130 within lumen 62. This constriction causes clamp seal60 to firmly hold or clamp onto device 130. Tightening threaded cap 100and consequent clamping of clamp seal 60 allows hands free operation forthe operator of bleed back control assembly 1.

As noted above, threaded cap 100 may be unscrewed or loosened byrotating threaded cap 100 to cause it to move proximally. This looseningof threaded cap 100 will correspondingly cause seal holder 80 to moveproximally as well, since seal holder 80 is connected to threaded cap100. As discussed above and referring to FIGS. 2 and 3, in oneembodiment, seal cavity 14 includes a snap insert 25 which is formed orconnected to the interior surface of seal cavity 14. Snap insert 25includes a blocking notch 27 which extends into seal cavity 14.

Distal to blocking notch 27 there is a corresponding restrictor notch 83formed on the exterior surface of seal holder 80. The relative spacingbetween blocking notch 27 and restrictor notch 83 permits threaded cap100 to be unscrewed a sufficient amount to open clamp seal 60. However,as threaded cap 100 is unscrewed further, restrictor notch 83 of sealholder 80 will impact blocking notch 27, preventing further unscrewingof threaded cap 100. Thus, the restrictive interlocking of blockingnotch 27 and restrictor notch 83 will prohibit threaded cap 100 fromunscrewing completely from threads 21 of seal cavity 14. The combinedeffect of blocking notch 27 and restrictor notch 83 ensures that sealbody 40 will remain attached to side arm body 10 even when threaded cap100 is unscrewed as completely as possible.

Operation of Bleed Back Control Seal

As noted above, in one embodiment, seal body 20 may comprise bleed backseal 70, but not include clamp seal 60. In an alternate embodiment, sealbody 20 may comprise both clamp seal 60 and bleed back seal 70. In bothembodiments, bleed back seal 70 operates to control fluid loss duringuse of bleed back control assembly 1.

Bleed back control seal 70 is normally closed unless acted upon. Theuser of bleed back control assembly 1 may open bleed back control seal70, by dilating aperture or pinhole 74. Because bleed back control seal70 has an aperture 74 in the center of web area 72, and because thematerial of bleed back control seal 70 is highly elastic and resilient,stretching of web area 72 will cause aperture 74 to open larger, thusallowing bleed back control seal 70 to open. Because of the elastic andresilient properties of web area 72's material, web area 72 will returnto the original, closed position when released after being stretched,thus allowing aperture 74 to close again. Operation of bleed backcontrol seal 70 is discussed with reference to FIGS. 2, 3, 13 a to 13 d,14 a to 14 e, and 15 a to 15 d.

The user may push or press funnel cap 90 and thus move dilator 92distally to open or dilate bleed back control seal 70. A user of bleedback control assembly 1 may depress funnel cap 90 axially towards distalend 16 of side arm body 10. This pressing or engaging of funnel cap 90will also cause dilator 92 to move axially and distally. As shown inFIGS. 13a to 13 d, when funnel cap 90 is pushed, dilator 92 will abutweb area 72 of bleed back control seal 70.

Axial movement of funnel cap 90 and dilator 92 causes bleed back controlseal 70 to open by stretching the material of web area 72 distally. Webarea 72 will be stretched and pushed into chamber 73 of bleed backcontrol seal 70. This stretching of web area 72 will cause aperture 74to open wider or dilate. Pushing funnel cap 90 also causes spring 110 toconstrict or compress. As shown in FIG. 13d, dilator 92 may be moveddistally until dilator 92 is blocked by impact with risers 87 and distallegs 86 of seal holder 80.

Referring to FIGS. 13a to 13 d, the diameter of bottom chamber 73 formedby side arms 76 of bleed back control seal 70 is larger than thediameter of dilator 92. This difference in diameters provides a breakaway for the material of web area 72 as web area 72 is pushed andstretched into bottom chamber 73 as dilator 92 moves distally.

Return spring 110, wound around the exterior of dilator 92 and insidechamber 94 of funnel cap 90, causes funnel cap 90 to return to thestarting, original position when the user releases or stops pushingfunnel cap 90. The decompressing action of spring 110 moves dilator 92proximally, thus allowing bleed back control seal 70 to return to itsoriginal shape and close aperture 74 again. Removal of dilator 92 awayfrom web area 72 of bleed back control seal 70 causes bleed back controlseal 70 to close by allowing the resilient material of web area 72 toreturn to its original shape and position. As the elastic material ofweb area 72 contracts back to its original shape, aperture 74 willcorrespondingly grow smaller, until eventually aperture 74 formed in webarea 72 of bleed back control seal 70 will close.

In one embodiment, threaded cap 100 does not cause dilation or openingof bleed back control seal 70. Threaded cap 100 may be operated asdiscussed above to rotate and thus cause seal holder 80 to move axially.As noted above, threaded cap 100 has interior arms 101 which abut orengage the proximal end 78 of bleed back control seal 70. Thus,tightening of threaded cap 100 causes corresponding movement axially ofseal holder 80 and bleed back control seal 70 without causing dilationof aperture 74 of web area 72.

In an alternate embodiment, dilator 92 may be attached to threaded cap100 (as opposed to funnel cap 90), and in this embodiment rotation oradjustment of threaded cap 100 will cause dilator 92 to impact and openaperture 74 of web area 72 of bleed back control seal 70. Thus, in thisembodiment, threaded cap 100 is operated by the user to open and closebleed back control seal 70.

During use of bleed back control assembly 1, a user may decide tointroduce a device 130 (such as a catheter or guidewire) into the bleedback control assembly 1. Referring to FIGS. 14a to 14 e, the user mayinsert a device 130 into funnel surface 96 of funnel cap 90. Device 130then continues into the lumen of dilator 92. Device 130 then movesthrough aperture 74 of bleed back control seal 70. (The user may decideto dilate or not dilate aperture 74 depending on the user's desires orthe size of device 130). Device 130 then continues through aperture 82in the bottom of seal holder 80, and thence into lumen 62 of clamp seal60. Then, device 130 will enter lumen 18 of side arm body 10. Continuedinsertion will cause device 130 to move through lumen 18, through lumen52 in luer connector 50, and ultimately into the patient's body in anysuitable or desired location and structure, either transluminally,transvenously, or in any other appropriate diagnostic or interventionalmanner.

Dilation of bleed back control seal 70 is not necessary for insertion ofmany devices 130, such as catheters and guidewires. Referring to FIGS.15a to 15 d, a user has the option to dilate aperture 74 of bleed backcontrol seal 70 before inserting a device 130 through aperture 74. Inorder to introduce a larger device 130 such as a stent with associateddelivery system, a user may engage funnel cap 90 and dilator 92, pushthem axially and distally, and thereby open or dilate aperture 74 ofbleed back control seal 70 to allow greater ease of insertion of device130.

An operator of bleed back control assembly 1 may thus introduce aguidewire, catheter, or other desired device 130 through funnel cap 90into dilator 92, through dilated aperture 74 of bleed back control seal70, through bottom chamber 73 of bleed back control seal 70, throughaperture 82 of seal holder 80, through lumen 62 of clamp seal 60, theninto primary lumen 18 of side arm body 10, and ultimately into thepatient.

A device 130 may be removed by withdrawing device 130 back through thesesame structures in reverse order. Both during insertion and withdrawal,the user may choose to dilate or stop dilating aperture 74 of bleed backcontrol seal 70, at any time.

One of ordinary skill would understand that device 130 may be anyappropriate transluminal or interventional device. For example, device130 may be a catheter, stent, guidewire, balloon catheter, or any othersuitable device. A user desiring to introduce a stent into bleed backcontrol assembly 1 may introduce the stent without necessarily requiringuse of dilator 92 to open aperture 74 of bleed back control seal 70.Guidewires may be introduced into bleed back control assembly 1 with anintroducer and, if an introducer is used, then bleed back control seal70's aperture 74 does not need to be opened with dilator 92. A ballooncatheter may also be introduced into bleed back control assembly 1without necessarily dilating bleed back control seal 70.

Because of the elastic and resilient material properties of bleed backcontrol seal 70, bleed back control seal 70's web area 72 is self sizingaround device 130 introduced through aperture 74. Bleed back controlseal 70 thus inhibits the loss of blood or other fluids when a user hasinserted a device 130 through aperture 74 of bleed back control seal 70.Bleed back control seal 70 thus controls fluid or blood loss both withand without devices 130 intratubal. A device 130 penetrating bleed backcontrol seal 70 can be moved into and out of side arm body 10 withsubstantially low fluid leakage and resistance.

A user may manipulate funnel cap 90 (and thus dilator 92) to open bleedback control seal 70 and allow the purging of gases or undesired fluidsfrom the interior of bleed back control assembly 1. A user may push orpress funnel cap 90 and dilator 92 to cause aperture 74 to open, andthis will allow the pressure of fluids within bleed back controlassembly 1 to purge gases or fluids trapped inside assembly 1, bycausing the gases or fluids to exit dilator 92 and out through theproximal end of assembly 1.

As noted above, bleed back control seal 70 in the closed position canwithstand pressures of at least approximately 40-100 psi withoutleaking. As noted above, if an alternate embodiment of web area 72 andaperture 74 is used, as in FIG. 5c, then bleed back control seal 70 inthe closed position can withstand pressures of approximately 500 psi. Asnoted above, an alternate embodiment for bleed back control seal 70 mayinclude spherical portion 79 as shown in FIG. 5d. In this embodiment,bleed back control seal 70 in the closed position may withstandpressures of approximately 400 psi. Therefore, even when clamp seal 60is in the open position, bleed back control seal 70 (which is normallyclosed) can prevent leakage of fluid out of the proximal end of bleedback control assembly 1. This may be advantageous, for example, when theuser performs injections through secondary branch 13 of the side armbody 10 at appropriate pressures while clamp seal 60 is open.

Accordingly, bleed back control assembly 1 of the present inventionprovides blood loss control during insertion, movement, and removal ofdevices 130 from assembly 1. Assembly 1 can be adjusted to clamp anintratubal device 130 to maintain device position.

Moreover, closure of clamp seal 60 with or without a device 130intratubal to assembly 1 allows the user to introduce high pressureinjections through lumen 15 of secondary branch 13 of the side arm body10.

Other Embodiments

While several aspects of the invention have been described with regardto specific embodiments, those skilled in the art will recognize thatchanges can be made in form and detail without departing from the spiritand scope of the invention.

In one embodiment, the approximate dimensions of some of the componentsof side arm body 10 and seal body 40 may be approximately as follows:

COMPONENT DIMENSIONS (in inches, ±0.005) Side arm body 10 Overalllength: 1.82 Length of secondary branch 13: 1.15 Length of seal cavity14: 0.46 Interior diameter of seal cavity 14: 0.38 Diameter of primarylumen 18: 0.12 Diameter of secondary lumen 15: 0.17 Clamp seal 60Length: 0.26 Max. diameter of frustum portion 61: 0.39 Length of frustumportion 61: 0.05 Length of cylinder portion 63: 0.03 Length of cylinderportion 65: 0.10 Length of cylinder portion 67: 0.08 Width of cylinderportion 63: 0.39 Width of cylinder portion 65: 0.37 Width of cylinderportion 67: 0.27 Diameter of top aperture of lumen 62: 0.1 Diameter ofbottom aperture of lumen 62: 0.12 Bleed back Length: 0.35 control seal70 Maximum width: 0.31 Diameter of top lumen 75: 0.14 Diameter of bottomlumen 73: 0.16 Seal holder 80 Length: 0.54 Diameter of top chamber 88:0.29 Diameter of bottom chamber 85: 0.25 Length of top chamber 88: 0.43Length of bottom chamber 85: 0.08 Length of aperture 82: 0.06 Diameterof aperture 82: 0.10 Funnel cap 90 Length: 0.90 Exterior diameter: 0.71Diameter of interior chamber 94: 0.60 Length of dilator 92: 0.46Diameter of lumen of dilator 92: 0.98 Threaded cap 100 Length: 0.36Diameter: 0.59 Proximal diameter of center hole 102: 0.15 Distaldiameter of center hole 102: 0.19

Those of ordinary skill will appreciate that the various components andsub-assemblies described with respect to alternate embodiments may berearranged or combined with each other without departing from the scopeof the invention. For example, components of cap assembly 30 may beincorporated as part of seal assembly 20, and vice versa. As notedabove, seal body 20 may not include clamp seal 60 in one embodiment.Also, structures of threaded cap 100 may be incorporated in funnel cap90, and vice versa.

Alternate embodiments also include adding a position lock for engagingand disengaging funnel cap 90 and dilator 92 (analogous to the manner bywhich a conventional ball point pen is depressed), thus requiring a userto engage or depress funnel cap 90 axially in order to engage anddisengage dilator 92 from opening bleed back control seal 70.

Alternatively, funnel cap 90 and dilator 92 may be locked or unlocked inthe open or closed positions with a bayonet style lock, where the lockmode would allow the operator to lock dilator 92 in either the open orclosed position to either dilate or not dilate aperture 74 of bleed backcontrol seal 70, whichever is desired.

Other embodiments include using a locking mechanism, such as a detent,using a twist motion of funnel cap 90 (of any suitable predeterminedamount of rotation) for locking dilator 92 in the open or closedpositions.

In another embodiment, side arm body 10 comprises primary branch 11 anddoes not include secondary branch 13. In this embodiment, finger rest 19may be formed on the exterior surface of primary branch 11 of side armbody 10.

In another embodiment, there may be a plurality of secondary branches 13in addition to primary branch 11 of side arm body 10. In thisembodiment, none, some, or all of these plurality of secondary branches13 may have their own finger rest 19 formed thereon, in addition to orin substitution for a finger rest 19 formed on the exterior surface ofprimary branch 11.

In another embodiment, side arm body 10, snap insert 25, luer connector50, seal holder 80, funnel cap 90, threaded cap 100, spring 110, andsnap retainer 120 may each be formed of other appropriate rigidmaterials or composite materials, such as metal, metallic alloys, otherresins, different plastics, glass, or any suitable composite.

In another embodiment, device 130 may be any device appropriate forinserting into any part of a patient's body, such as insertion into ablood vessel or any other luminal structure or any body cavity. Forexample, device 130 may be any type of catheter, guidewire, stent,balloon catheter, perfusion balloon, guiding catheter, rapid exchangecatheter, over-the-wire balloon, directional coronary atherectomycatheter, or other appropriate device.

Persons of ordinary skill will appreciate that changes can be made todimensions, sizing, relative dimensions, materials, spatial and angularrelationships of and between components, and manufacturing processes andother commercial or industrial techniques, all without departing fromthe scope of the invention.

We claim:
 1. A bleed back control assembly comprising: a side arm bodyhaving a proximal end, a distal end, and a lumen connecting saidproximal and distal ends, said side arm body also having a seal cavityformed in said proximal end, said lumen being in fluid communicationwith said seal cavity; a seal mechanism coupled to the proximal end ofsaid side arm body, said seal mechanism comprising: a cap assemblycoupled to a seal assembly and coupled to said proximal end of said sidearm body, said cap assembly restraining said seal assembly within saidseal cavity and said cap assembly operable to engage said seal assemblyin response to active user manipulation and disengage from said sealassembly in the absence of active user manipulation and said capassembly having a lumen having a proximal aperture communicating withthe exterior of said cap assembly; and said seal assembly comprisingelastomeric material inhibiting said cap assembly lumen from being influid communication with said side arm body lumen; and wherein said capassembly is operable to control axial translation and displacement ofsaid seal mechanism; and wherein displacement of said cap assembly islimited by one or more stop means, wherein said stop means comprises oneor more notches formed in the interior of said cap assembly.
 2. A bleedback control assembly comprising: a side arm body having a proximal end,a distal end, and a lumen connecting said proximal and distal ends, saidside arm body also having a seal cavity formed in said proximal end,said lumen being in fluid communication with said seal cavity; a sealmechanism coupled to the proximal end of said side arm body, said sealmechanism comprising: a cap assembly coupled to a seal assembly andcoupled to said proximal end of said side arm body, said cap assemblyrestraining said seal assembly within said seal cavity and said capassembly operable to engage said seal assembly in response to activeuser manipulation and disengage from said seal assembly in the absenceof active user manipulation and said cap assembly having a lumen havinga proximal aperture communicating with the exterior of said capassembly; and said seal assembly comprising elastomeric materialinhibiting said cap assembly lumen from being in fluid communicationwith said side arm body lumen; and wherein said seal cavity has aninterior distal surface including an aperture allowing fluidcommunication between said side arm body lumen and said seal cavity,said seal assembly comprising: a seal holder which is movable axially,said seal holder distal to said lumen aperture and having an interiorchamber; and a bleed back control seal held within said interior chamberof said seal holder, said bleed back control seal having an aperturewhich is closed unless acted upon for controlling blood loss duringoperation of said assembly; and further wherein said cap assemblycomprises a dilator, said dilator operable to be forcibly introducedthrough said aperture of said bleed back control seal.
 3. A bleed backcontrol assembly comprising: a side arm body having a proximal end, adistal end, and a lumen connecting said proximal and distal ends, saidside arm body also having a seal cavity formed in said proximal end,said lumen being in fluid communication with said seal cavity; a sealmechanism coupled to the proximal end of said side arm body, said sealmechanism comprising: a cap assembly coupled to a seal assembly andcoupled to said proximal end of said side arm body, said cap assemblyrestraining said seal assembly within said seal cavity and said capassembly operable to engage said seal assembly in response to activeuser manipulation and disengage from said seal assembly in the absenceof active user manipulation and said cap assembly having a lumen havinga proximal aperture communicating with the exterior of said capassembly; and said seal assembly comprising elastomeric materialinhibiting said cap assembly lumen from being in fluid communicationwith said side arm body lumen; and wherein said seal cavity has aninterior distal surface including an aperture allowing fluidcommunication between said side arm body lumen and said seal cavity,said seal assembly comprising: a seal holder which is movable axially,said seal holder distal to said lumen aperture and having an interiorchamber; and a bleed back control seal held within said interior chamberof said seal holder, said bleed back control seal having an aperturewhich is closed unless acted upon for controlling blood loss duringoperation of said assembly; and wherein said cap assembly comprises: adilator and a spring wound around said dilator, said spring pushingunidirectionally.
 4. A bleed back control assembly comprising: a sidearm body having a proximal end, a distal end, and a lumen connectingsaid proximal and distal ends, said side arm body also having a sealcavity formed in said proximal end, said lumen being in fluidcommunication with said seal cavity; a seal mechanism coupled to theproximal end of said side arm body, said seal mechanism comprising: acap assembly coupled to a seal assembly and coupled to said proximal endof said side arm body, said cap assembly restraining said seal assemblywithin said seal cavity and said cap assembly operable to engage saidseal assembly in response to active user manipulation and disengage fromsaid seal assembly in the absence of active user manipulation and saidcap assembly having a lumen having a proximal aperture communicatingwith the exterior of said cap assembly; and said seal assemblycomprising elastomeric material inhibiting said cap assembly lumen frombeing in fluid communication with said side arm body lumen; and whereinsaid seal cavity has an interior distal surface including an apertureallowing fluid communication between said side arm body lumen and saidseal cavity, said seal assembly comprising: a seal holder which ismovable axially, said seal holder distal to said lumen aperture andhaving an interior chamber; and a bleed back control seal held withinsaid interior chamber of said seal holder, said bleed back control sealhaving an aperture which is closed unless acted upon for controllingblood loss during operation of said assembly, wherein said bleed backcontrol seal is movable axially in response to user manipulation of saidcap assembly.
 5. A bleed back control assembly comprising: a side armbody having a proximal end, a distal end, and a lumen connecting saidproximal and distal ends, said side arm body also having a seal cavityformed in said proximal end, said lumen being in fluid communicationwith said seal cavity; a seal mechanism coupled to the proximal end ofsaid side arm body, said seal mechanism comprising: a cap assemblycoupled to a seal assembly and coupled to said proximal end of said sidearm body, said cap assembly restraining said seal assembly within saidseal cavity and said cap assembly operable to engage said seal assemblyin response to active user manipulation and disengage from said sealassembly in the absence of active user manipulation and said capassembly having a lumen having a proximal aperture communicating withthe exterior of said cap assembly; and said seal assembly comprisingelastomeric material inhibiting said cap assembly lumen from being influid communication with said side arm body lumen; and wherein said sealcavity has an interior distal surface including an aperture allowingfluid communication between said side arm body lumen and said sealcavity, said seal assembly comprising: a seal holder which is movableaxially, said seal holder distal to said lumen aperture and having aninterior chamber; and a bleed back control seal held within saidinterior chamber of said seal holder, said bleed back control sealhaving an aperture which is closed unless acted upon for controllingblood loss during operation of said assembly, and wherein said bleedback control seal comprises a valve which is operable to be closed whenin a resting idle position and open when in an active working position,whereby opening of said valve allows passage of an interventional deviceinto the lumen of said bleed back control assembly.